Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT00006359
Last Updated: 2016-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2000-09-30
2012-03-31
Brief Summary
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PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
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Detailed Description
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* Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
* Determine the safety of EBRT+BT in these patients.
* Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.
OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.
Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Androgen suppression + EBRT + Brachytherapy
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
LHRH agonist
Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
antiandrogen
flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
radiation therapy
4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
Brachytherapy boost
Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
Interventions
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LHRH agonist
Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
antiandrogen
flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
radiation therapy
4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
Brachytherapy boost
Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the prostate
* Must have one of the following prognostic factors:
* Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score \> 6
* Stage T1-2, N0; PSA \> 10 ng/mL and \< 20 ng/mL; and Gleason score ≤ 6
* Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6
* Prostate volume \< 60 cc by transrectal ultrasound
* No distant or nodal metastases
* No metastatic disease by bone scan, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* Bilirubin ≤ 1.5 times upper limit of normal
Renal:
* Not specified
Other:
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for prostate cancer
Chemotherapy:
* No prior chemotherapy for prostate cancer
Endocrine therapy:
* Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy
* No other prior hormonal therapy
Radiotherapy:
* No prior radiotherapy for prostate cancer
Surgery:
* No prior surgery for prostate cancer
* No prior transurethral resection of the prostate
Other:
* No prior alternative therapy (e.g., PC-SPES) for prostate cancer
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Mark Hurwitz, MD
Role: STUDY_CHAIR
Dana-Farber/Brigham and Women's Cancer Center
Locations
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Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
St. Francis Hospital
Wilmington, Delaware, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital
Fall River, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Arch Medical Services, Incoroporated at Center for Cancer Care Research
St Louis, Missouri, United States
Washoe Cancer Services at Washoe Medical Center - Reno
Reno, Nevada, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Community General Hospital of Greater Syracuse
Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Danville Regional Medical Center
Danville, Virginia, United States
Countries
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References
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Hurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010.
Hurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: an initial report of CALGB 99809. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):814-9. doi: 10.1016/j.ijrobp.2008.01.010. Epub 2008 Apr 11.
Other Identifiers
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CALGB-99809
Identifier Type: -
Identifier Source: secondary_id
CDR0000068228
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-99809
Identifier Type: -
Identifier Source: org_study_id
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